Efficacy and Safety Study of ME-609 and Acyclovir for Treatment of Herpes Simplex Labialis

This study has been completed.
Sponsor:
Collaborator:
-
Information provided by:
Medivir
ClinicalTrials.gov Identifier:
NCT00361881
First received: August 8, 2006
Last updated: August 14, 2008
Last verified: August 2008
  Purpose

The purpose of this study is to determine whether ME-609 is more efficient than acyclovir and placebo for the treatment of recurrent herpes labialis.


Condition Intervention Phase
Herpes Labialis
Drug: ME-609
Drug: acyclovir in ME-609 vehicle
Drug: Vehicle
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized, Double-Blind, Active Controlled, Vehicle-Controlled, Subject Initiated Study Comparing Efficacy and Safety of ME-609 Versus Acyclovir Cream for Treatment of Recurrent Herpes Simplex Labialis

Resource links provided by NLM:


Further study details as provided by Medivir:

Primary Outcome Measures:
  • Proportion of subjects with non-ulcerative recurrences measured as the proportion of subjects in whom the study recurrence did not progress beyond the papule stage. [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Episode duration [ Time Frame: until healing ] [ Designated as safety issue: No ]

Enrollment: 1443
Study Start Date: July 2006
Study Completion Date: December 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
ME-609
Drug: ME-609
Cream, dose 5 times daily during 5 days.
Active Comparator: 2
Acyclovir in ME-609 vehicle
Drug: acyclovir in ME-609 vehicle
Dose 5 times daily for 5 days
Placebo Comparator: 3
Vehicle
Drug: Vehicle
Dose 5 times daily for 5 days

Detailed Description:

This was a randomized, double-blind, active- and vehicle-controlled study comparing the effects of ME-609, acyclovir in ME-609 vehicle, and vehicle alone. Treatment was subject-initiated within 1 hour of experiencing the first signs or symptoms of a herpes recurrence. The subject visited a study clinic as soon as possible after treatment initiation, but no later than midnight of the following day, for evaluation.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Generally good health
  • History of recurrent herpes labialis with at last three episodes during the prior 12 months

Exclusion Criteria:

  • Treatment with antivirals or immunosuppressive agents within 2 weeks prior to randomization
  • Pregnant and/or nursing women
  • Continuous daily treatment with pain medication
  • Significant skin condition that occur in the area of herpes recurrences
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00361881

Locations
United States, South Carolina
Coastal Caroline Research Center
Mt. Pleasant, South Carolina, United States, 29464
Sponsors and Collaborators
Medivir
-
Investigators
Principal Investigator: Christopher M Hull, MD
  More Information

No publications provided by Medivir

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Börje Darpö, MD, PhD, Medivir AB
ClinicalTrials.gov Identifier: NCT00361881     History of Changes
Other Study ID Numbers: 609-04
Study First Received: August 8, 2006
Last Updated: August 14, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Herpes Labialis
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Skin Diseases, Infectious
Skin Diseases
Acyclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014